The FDA has approved Augmentin XR, an oral antibacterial, under its Commissioner’s National Priority Voucher pilot program, marking the first approval granted through the expedited review pathway. The ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times.

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...

・The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit. ・The company submitted responses and the agency determined that the ...

The FDAAA did not significantly alter the overall time to first postmarket safety action for novel therapeutics. Earlier safety actions were observed within the first five years post-approval, ...